Shire Files Submission For FDA Approval To Manufacture Flexbumin At Georgia Site

(RTTNews) - Shire plc (SHP.L, SHPG), a biotechnology company focused on rare diseases, said Thursday that it has filed its second submission to the United States Food and Drug Administration or FDA for its new plasma manufacturing facility near Covington, Georgia.

This second submission is for the manufacturing of Flexbumin 25% [Albumin (Human)], USP, 25% Solution, a treatment primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions.

The Georgia facility received its first FDA approval, to manufacture Gammagard Liquid [Immune Globulin Infusion (Human)] 10% Solution.

Shire noted that the Georgia site currently employs about 900 full-time colleagues and contract employees. Since the beginning of 2018, Shire has ramped up hiring to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse, and various support and facility roles.

"We are very pleased to file this second submission for our state-of-the-art manufacturing facility in Georgia, after the facility received FDA approval earlier this year. Expanding our capacity for manufacturing FLEXBUMIN will allow us to better meet the increasing global demand for plasma protein therapies and further supports our growing immunoglobulin and bio-therapeutics portfolio by enabling us to deliver these important treatments to our patients," said Matt Walker, Head of Technical Operations for Shire.

Shire noted that it's Immunology franchise has seen strong demand, with product sales increasing 13 percent in the second quarter of 2018 versus the prior year.